August 2012 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-033-2013 - Cross Contamination w/Other Products

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on August 7, 2012 for the product Drug. The FDA reported the reason for recall as cross contamination w/other products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-033-2013

Reason for Recall
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Initiated
08-07-2012
Reported
10-31-2012
Quantity
24,331 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63284
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-27-2013
Product Description About Product Description
Full technical description of the product.
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***

Batch or Lot Expiration Information

Lot# Lot A 303M, Exp. June 2014